Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.

Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

This administrative supplement is designed to broaden the clinical research workforce with a specific focus on research coordinators. The supplement will provide funds to hire, train and support clinical research coordinators for up to two years to improve the outreach, recruitment, and community engagement of NIDDK clinical research studies, leading to more transformative research.

Background

Clinical studies and clinical trials are essential for finding appropriate strategies for the prevention and management of diseases across the entire U.S. population; therefore, full representation of the United States population in clinical research studies is critical to ensure optimal quality of medical care and biomedical research. Historically, clinical research study participants have not reflected the demographics of those who suffer from the diseases and conditions targeted by clinical research studies. Recognizing this need, the NIH has focused efforts and attention on the inclusion of women and minorities in clinical research as required by federal law (42 USC 289a-2) and NIH policy (NOT-OD-18-014 and NOT-OD-18-116). Although some progress has been made to reach and enroll individuals from underrepresented communities in clinical research, more work is still needed to meet the goal of enrolling research participants who are reflective of the U.S. population, particularly those with or at risk for diseases and conditions within NIDDK’s mission. NIDDK supports these concerted efforts as outlined in Pathways to Health for All: Health Disparities and Health Equity Research Recommendations and Opportunities.

Clinical research coordinators are central to the success of recruitment and retention of individuals in clinical studies. Individuals considering participation in clinical studies are often more comfortable and able to adhere to study protocols when approached and managed by research study coordinators who are culturally competent, have cultural humility, and are reflective of their corresponding communities. However, only a small percentage of clinical research coordinators come from communities who are underrepresented in research and at risk for NIDDK diseases. Therefore, this Notice of Special Interest is intended to provide support for currently funded NIDDK clinical studies to hire and train a research study coordinator to increase outreach and successfully enroll individuals from underrepresented groups in order to meet the goals of the clinical study.

Research Objectives  

Administrative Supplements will support one to two years of support for research coordinators in order to add to the breadth of perspectives and representation of the clinical research team. This additional coordinator effort should provide needed additional support for an identified research study coordinator to improve participant engagement, recruitment, and retention to support the success of the parent grant in enrolling and retaining research participants from populations and communities that experience health disparities. This opportunity is intended to provide initial support for an identified research study coordinator to gain the experience necessary to sustain a research career and should provide training and other activities necessary to achieve this goal. The supplemental funds cannot be used for PI effort or for current members of the research team. Additionally, the supplement objectives are to support the current scope of the parent grant and cannot be used to modify research aims or the research study population.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent. Applications that are not responsive to this NOSI will not be reviewed.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the How to Apply - Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) – February 14, 2025, February 16, 2026, February 15, 2027, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-DK-24-031” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for up to two years of support. 
• Limit of one supplement per parent grant.
• The Research Strategy section of the application is limited to 6 pages. The application should address the following:
  • The research study coordinator’s qualifications and how their participation will broaden the clinical research workforce;
  • What unmet need in recruitment and retention of the parent grant will be addressed with the supplement;
  • How the administrative supplement will increase recruitment and/or maintain retention of research participants, particularly those from populations that may experience health disparities, in the parent clinical research study;
  • The progress of the project to date. If progress in the parent study has been lagging and the addition of the candidate to the study team is intended to assist with increasing the rate of progress, describe how this will be accomplished with this administrative supplement;
  • The training of the identified research study coordinator and how this training will provide not only the ability of the candidate to assist in accomplishing the goals of the parent study, but also provide an experience base for the candidate to pursue further employment as a clinical research study coordinator and transition into a more permanent position;
  • The mentoring or training experience of the individual(s) responsible for training the research study coordinator;
  • How the outcomes of this supplement will be collected and reported. The focus should be on associated improvements in recruitment and retention in the parent study and professional development of the identified research study coordinator.
• Letters of Support—Provide a Letter(s) of Support describing institutional commitment to the identified research study coordinator (e.g., protected time, policies, programs, resources, and other strategies), commitment to the study coordinator’s continued professional development, and a plan for the study coordinator after the supplement ends, such that they will become competitive for future clinical research opportunities.
• Administrative supplement applications to PA-20-272 must use the application form package with the Competition ID that contains “FORMS-I-ADMIN SUPP”. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this NOSI in order to facilitate efficient processing of the request.

Budget:

To be eligible, the parent award must be able to receive funds at the time of the award and have at least two years remaining on the clinical research study. The administrative supplement budget is limited to two years. The application budget cannot exceed a maximum direct cost of $100,000 per year, commensurate with training and appropriateness for geographic location. Applicable F & A (indirect) cost can also be requested.

Funds can be used to cover the salary, training, and other activities necessary for the research coordinator to sustain a research career. The research coordinator is required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months).

Scope of Support

The number of awards is contingent upon NIDDK appropriations and the submission of a sufficient number of meritorious applications.

NIDDK intends to commit at least $640,000 in FY 2025 for this funding opportunity.

The proposed project period must be contained within the awarded project period of the parent award.

Administrative Review Process

NIDDK will conduct administrative reviews of applications submitted. NIDDK will support the most meritorious applications submitted for consideration, pending availability of funds.

Inquiries

Please direct all inquiries to:

Katrina Serrano, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-7855
Email: [email protected]